FDA 510(k)

TotalC-Ram

K-Number: K162960 · 2017-03-14

Decision Date2017-03-14

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

TotalC-Ram is the device name listed in this FDA 510(k) record. The listed applicant is Itena Clinical. It received FDA 510(k) clearance on 2017-03-14 under 510(k) number K162960. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TotalC-Ram?

TotalC-Ram is a medical device that received FDA 510(k) clearance on 2017-03-14. The listed applicant is Itena Clinical. The 510(k) number is K162960.

When did TotalC-Ram receive FDA 510(k) clearance?

TotalC-Ram received FDA 510(k) clearance on 2017-03-14, under 510(k) number K162960.

Who is the listed applicant for TotalC-Ram?

The FDA 510(k) record lists Itena Clinical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TotalC-Ram?

The FDA product code for TotalC-Ram is EMA.

Other records listing Itena Clinical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170207Obturys

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.